Preparing a Clinical Evaluation Report (part 1)

Preparing a good quality clinical evaluation report for submission to the notified body is vital to ensure they understand your device.

In this Webinar:

Speakers

Speaker

Head of Clinical Compliance, BSI

Speaker

Head of Life Sciences- Regulatory & Policy, BSI

Ensure your product maintains EU market access under the new, more stringent Medical Device Regulations (MDR).

Performing a robust clinical evaluation plan is a critically important step and if not done correctly can undermine your overall clinical evaluation.

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Understand how best to document clinical investigations, including expectations around supporting documentation related to clinical investigations.

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This webinar will focus on how best to document PMCF plans and evaluation reports.

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The summary of safety and clinical performance (SSCP) is a new requirement under the MDR.

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